MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-04-18 for COOK CERVICAL RIPENING BALLOON WITH STYLET manufactured by Cook Medical.
[73377173]
Cook cervical ripening balloon with stylet pierced the end of the catheter during placement and could have cut the baby or ruptured the amniotic membrane, the stylet extended 1cm past the end of catheter tip. Route: vaginal. Is the product compounded: no. Is the product over the counter: no.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5069207 |
| MDR Report Key | 6507449 |
| Date Received | 2017-04-18 |
| Date of Report | 2017-04-18 |
| Date of Event | 2017-04-12 |
| Date Added to Maude | 2017-04-20 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | COOK CERVICAL RIPENING BALLOON WITH STYLET |
| Generic Name | COOK CERVICAL RIPENING BALLOON WITH STYLET |
| Product Code | HDY |
| Date Received | 2017-04-18 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK MEDICAL |
| Manufacturer Address | BLOOMINGTON IN 47404 US 47404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-04-18 |